(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00801803602, cocr femoral head, 61357236; 00784802401, modular kinectiv neck, 60921924; 00620005422, trilogy cup, 61316054; 00630505036, xlpe liner, 61379632; 00625006525, bone scr 6.5x25 self-tap, 61412713.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2017 - 03500, 0001822565 - 2017 - 03504, 0002648920 - 2017 - 00542, 0001822565 - 2017 - 06209.
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It was reported by legal counsel that the patient underwent a left hip aspiration due to a lump around her left buttock that had enlarged, causing sleep and functional impairments.It was noted that the fluid was discolored, thick, and difficult to aspirate.No additional patient consequences were reported.
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